ACNE CONTROL- cream cream

Acne Control by

Drug Labeling and Warnings

Acne Control by is a Otc medication manufactured, distributed, or labeled by Walgreen, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

For the treatment of acne.

Warnings

For external use only.

When using this product

• Skin irritation and drynessis more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• Cover the entire affected area with a thin layer one to three times daily.
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• Rinse off after use.

Sensitivity Test for a New user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.

Inactive Ingredients

Water (Aqua), Cocamidopropyl hydroxysultaine, Glycerin, Sodiumj Lauroyl sarcosinate, Sodium Methyl Cocvoyl Taurate, PEG-150 Pentaerythrityl Tetrastearate, Niacinamide, Ceramide NP, Ceramide AP, Ceramide EOP, Carbomer, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Hydrolyzed Hyaluronic Acid, Disodium EDTA, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Xanthan gum, Citric Acid, Sodium Hydroxide.

Label Copy

INGREDIENTS AND APPEARANCE

ACNE CONTROL 
cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5834
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2000 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
TOCOPHEROL (UNII: R0ZB2556P8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
CERAMIDE AP (UNII: F1X8L2B00J)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CERAMIDE 1 (UNII: 5THT33P7X7)
HYALURONIC ACID (UNII: S270N0TRQY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
CERAMIDE NP (UNII: 4370DF050B)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-5834-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/11/2023

Labeler - Walgreen (008965063)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(0363-5834)